Heart valve delivery catheter with safety button

ABSTRACT

Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. Catheter assemblies according to the present invention can include a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A safety button can be included on the handle assembly to allow for precise and consistent positioning of the prosthetic valve in the body. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of prior U.S. patent application Ser.No. 15/657,680, filed Jul. 24, 2017, now U.S. Pat. No. 10,799,352, whichis a continuation of prior U.S. patent application Ser. No. 14/556,408,filed Dec. 1, 2014, now U.S. Pat. No. 9,782,257, which is a divisionalof prior U.S. patent application Ser. No. 13/016,658, filed Jan. 28,2011, now U.S. Pat. No. 8,926,693, which claims benefit under 35 U.S.C.119(e) to U.S. Provisional Patent Application 61/305,488, filed Feb. 17,2010, each of which is incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to heart valve delivery catheters andmethods of delivering and implanting heart valves using deliverycatheters. More specifically, the present invention relates to adelivery catheter with an improved handle design for controllingdelivery of a heart valve via the catheter.

Background

Recently, minimally invasive approaches have been developed tofacilitate catheter-based implantation of valve prostheses on thebeating heart, intending to obviate the need for the use of classicalsternotomy and cardiopulmonary bypass. For example, French PatentApplication No. 99 14462 illustrates a technique and a device for theablation of a deficient heart valve by percutaneous route, with aperipheral valvular approach. International Application (PCT) Nos. WO93/01768 and WO 97/28807, as well as U.S. Pat. No. 5,814,097 to Stermanet al., U.S. Pat. No. 5,370,685 to Stevens, and U.S. Pat. No. 5,545,214to Stevens illustrate techniques that are not very invasive as well asinstruments for implementation of these techniques.

U.S. Pat. No. 3,671,979 to Moulopoulos and U.S. Pat. No. 4,056,854 toBoretos describe catheter-mounted artificial heart valves forimplantation in close proximity to a defective heart valve. Both ofthese prostheses are temporary in nature and require continuedconnection to the catheter for subsequent repositioning or removal ofthe valve prosthesis, or for subsequent valve activation.

With regard to the positioning of a replacement heart valve, attaching avalve on a support with a structure in the form of a wire or network ofwires, forming a frame, has been proposed. This frame can be contractedradially in such a way that it can be introduced into the body of thepatient percutaneously by means of a catheter, and it can be deployed soas to be radially expanded once it is positioned at the desired targetsite. U.S. Pat. No. 3,657,744 to Ersek discloses a cylindrical,frame-supported, tri-leaflet tissue heart valve that can be deliveredthrough a portion of the vasculature using an elongate tool. The frameis mounted onto the expansion tool prior to delivery to the targetlocation where the frame and valve are expanded into place.

Current techniques for delivering prosthetic heart valves via a catheterinclude a transapical approach for aortic valve replacement, typicallyinvolving the use of an introducer port, i.e., a large-bore overtube, ofa trocar. A crimped, framed valve prosthesis reversibly coupled to adelivery catheter is transcatheterally advanced toward the native valve,where it is either forcefully deployed using a balloon catheter, or,alternatively, passively deployed using a self-expandable system.Accurate positioning of the replacement valve in the native annulus iscritical to the success of the implantation. Although prior deliverycatheter assemblies are sufficient to delivery a prosthetic valve to thenative annulus, they do not provide a precise release mechanism for thevalve such that error in placing the prosthetic valve in the nativeannulus is reduced.

The present invention provides a delivery catheter with an improvedhandle design for controlling delivery of a heart valve via thecatheter. Delivery catheters according to embodiments of the presentinvention can include two or more rotatable control knobs on thecatheter handle. These control knobs allows for accurate manipulation ofthe distal tip of the catheter. A safety button can be included on thecatheter handle to further improve implantation accuracy. Deliverycatheters according to embodiments of the present invention can alsoallow for further adjustment of the delivery position of a prostheticvalve retained by the distal tip of the catheter after a portion of theprosthetic valve has been exposed to the body channel.

BRIEF SUMMARY OF THE INVENTION

The catheter assemblies described herein seek to remedy one or more ofthe disadvantages of previous heart valve delivery catheters byproviding catheters that allow for precise control of the release pointof a prosthetic heart valve within the body. The catheter assembliesprovided herein can also include components that limit trauma to theexpanded prosthetic valve and body channels as the distal tip of thecatheter is withdrawn through the expanded valve and thereafter from thebody. In one embodiment, a catheter assembly according to the presentinvention includes a handle assembly, an introducer sheath, and a distaltip assembly. The handle assembly can include a fixed main handle andtwo or more rotating handles that allow a user to control the distal tipassembly of the catheter. The handle assembly can also include safetybuttons to lock the rotating handles in a desired position correspondingto one stage of delivery. The distal tip assemblies described herein caninclude a slotted tip for breaching the apex of the heart during atransapical delivery approach. Distal tip assemblies may also includetwo or more sleeves for retaining a prosthetic valve prior to deploymentof the prosthetic valve. A valve retaining mechanism can be included toassist in retaining the prosthetic valve prior to deployment. Eachcontrol knob on the handle assembly controls a portion of the componentson the distal tip of the catheter by allowing for precise manipulationof various delivery shafts. A safety button can be included to allow forprecise and consistent positioning of the prosthetic valve in the body.Each delivery shaft extends from the handle assembly to respectivepositions towards the distal end of the catheter. Preferably, rotatingone of the control knobs causes a distal sleeve on the distal tip of thecatheter to move in a distal direction, thereby at least partiallyreleasing a prosthetic valve. Rotating a second one of the control knobscan cause a proximal sleeve on the distal tip of the catheter to move ina proximal direction, thereby fully releasing a self-expandingprosthetic valve at a desired location in the body. Once the valve isdeployed, the catheter can be withdrawn from the body.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying figures, which are incorporated herein, form part ofthe specification and illustrate embodiments of heart valve deliverycatheters and methods of delivering and implanting heart valves usingdelivery catheters. Together with the description, the figures furtherserve to explain the principles of and to enable a person skilled in therelevant art(s) to make and use the delivery catheters and methods ofusing delivery catheters described herein. In the drawings, likereference numbers indicate identical or functionally similar elements.

FIG. 1 illustrates a closed catheter assembly in accordance with oneembodiment presented herein.

FIG. 2 illustrates the catheter assembly of FIG. 1 in an openconfiguration.

FIG. 3 is a depiction of the distal tip assembly and introducer of acatheter according to one embodiment of the present invention in aclosed configuration.

FIG. 4 illustrates the distal tip and introducer assemblies of acatheter in accordance with one embodiment presented herein in apartially open configuration.

FIG. 5 illustrates a delivery catheter handle in accordance with oneembodiment presented herein.

FIG. 6 illustrates a simplified interior of a delivery catheter handlein accordance with one embodiment of the present invention.

FIG. 7 illustrates a second simplified view of a portion of a deliverycatheter handle in accordance with one embodiment of the presentinvention.

FIG. 8 illustrates the distal tip assembly shown in FIGS. 3 and 4 in onestage of delivery.

FIG. 9 illustrates the distal tip assembly shown in FIGS. 3 and 4 in asecond stage of delivery.

FIG. 10 illustrates the distal tip assembly shown in FIGS. 3 and 4 in athird stage of delivery.

FIG. 11 illustrates the distal tip assembly shown in FIGS. 3 and 4 inone stage of withdrawal.

FIG. 12 illustrates the distal tip assembly and introducer shown inFIGS. 3 and 4 in a second stage of withdrawal.

FIG. 13 is a flow diagram that is used as an aid to describe a method ofimplanting a prosthetic heart valve in a patient.

FIG. 14 illustrates a delivery catheter handle in accordance with oneembodiment presented herein, including one embodiment of a support armrelease button.

FIG. 15 is a cross-sectional view of a delivery catheter handle inaccordance with the embodiment illustrated in FIG. 14 .

FIGS. 16A and 16B illustrate a delivery catheter handle and distal tipassembly of a delivery catheter according to one embodiment of thepresent invention at one stage of delivery.

FIGS. 17A and 17B illustrate a delivery catheter handle and distal tipassembly of a delivery catheter according to one embodiment of thepresent invention at a second stage of delivery. FIG. 17C illustrates inmore detail the features of the support arm release button and relatedcomponents.

FIGS. 18A and 18B illustrate a delivery catheter handle and distal tipassembly of a delivery catheter according to one embodiment of thepresent invention at a third stage of delivery.

FIGS. 19A and 19B illustrate a delivery catheter handle and distal tipassembly of a delivery catheter according to one embodiment of thepresent invention at a fourth stage of delivery.

FIG. 20 illustrates a delivery catheter handle according to oneembodiment presented, including an alternate support arm release buttonconfiguration.

FIG. 21 is a cross-sectional view of the delivery catheter handleillustrated in FIG. 20 , illustrating the support arm release button inone stage of operation.

FIG. 22 is a cross-sectional view of the delivery catheter handleillustrated in FIG. 20 , illustrating the support arm release button inanother stage of operation.

FIG. 23 is a cross-sectional view of the delivery catheter handleillustrated in FIG. 20 , illustrating the support arm release button inyet another stage of operation.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description of heart valve delivery catheters andmethods of delivering and implanting heart valves refers to theaccompanying figures that illustrate exemplary embodiments. Otherembodiments are possible. Modifications can be made to the embodimentsdescribed herein without departing from the spirit and scope of thepresent invention. Therefore, the following detailed description is notmeant to be limiting. Further, it would be apparent to one of skill inthe art that the systems and methods described below can be implementedin many different embodiments of hardware. Any actual hardware describedis not meant to be limiting. The operation and behavior of the systemsand methods presented are described with the understanding thatmodifications and variations of the embodiments are possible given thelevel of detail presented. For example, while the description providedis directed to catheters for transapical delivery of a heart valve, thecatheters and individual features of the catheters described hereinshould not be limited to transapical delivery of a heart valve. One ofskill in the art would readily understand how to incorporate thefeatures and structures described herein into catheters intended forother purposes. For example, features of the catheters described hereincan be incorporated into catheters intended for other types oftransluminal heart valve delivery as well as catheters intended forthorascopic heart valve delivery. Features of the catheters describedherein can also be incorporated into catheters designed for delivery ofstents or valves to areas of the body other than the heart.

FIG. 1 illustrates a catheter assembly 100 in accordance with oneembodiment presented herein. Catheter assembly 100 is depicted in FIG. 1in a closed configuration. Catheter assembly 100 generally includes ahandle assembly 102 located at the proximal end of the catheter, adistal tip assembly 104 located at the distal end of the catheter, andan introducer 116 slidably located along a outer delivery shaft 106between the distal tip assembly 104 and the handle assembly 102.

Outer delivery shaft. 106 is preferably a tubular flexible braidedstructure. Outer delivery shaft 106 can be formed of braided materialfabricated from materials such as, but not limited to, polyethylenenaphthalate (PEN), polyester (PET), stainless steel, titanium, nitinol,cobalt nickel alloy, polyimide, polyimide, or the like. In someembodiments, outer delivery shaft may contain reinforcing materials orstructures. These structures can include an inner layer of polymeroverlaid by a first reinforcing braid layer, overlaid by a coilreinforcement, finally overlaid with an outside layer of polymericmaterial. In another embodiment, the inner layer of polymeric materialis overlaid by the coil reinforcement, which is overlaid by the braidedreinforcement, which is finally overlaid with the outside layer of apolymeric material. In other embodiments, the inner layer of polymericmaterial is overlaid by a braided layer, which is overlaid by the coilwinding, which is overlaid by another layer of braid, which is in turnoverlaid by an outer polymeric layer. Preferably, however, anyreinforcing layer used allows outer delivery shaft 106 to retain adegree of flexibility. Other flexible materials can also be used to formouter delivery shaft 106 consistent with embodiments of the presentinvention.

Handle assembly 102 includes a main handle 108, a proximal control knob110, and a distal control knob 112. Main handle 108, a proximal controlknob 110, and distal control knob 112 can be formed of any suitablematerial. For example, in some embodiments the handle and control knobsare formed of a polymer material. Other materials are possible, as wouldbe understood in the art. A flushing port 114 can also be included onmain handle 108. Flushing port 114 can be used to de-air the catheterassembly. Also, the native annulus is exposed to the blood pressure in apatient's cardiovascular system during use of a heart valve deliverycatheter. As a consequence, in the absence of any counter pressure inthis annulus, blood can flow inside towards the proximal end of thecatheter, where it may coagulate and cause thrombosis. Thus, flushingport 114 can also allow fluid to be introduced into the native annulusto prevent such complications. In some embodiments, flush port 114 canalso be used for site specific drug delivery or to introduce radiopaquefluid into the body.

As will be described herein, proximal control knob 110, and distalcontrol knob 112 can be manipulated by a user in order to controloperation of the distal tip assembly 104 of catheters described herein.A detailed description of the operation and structure of handle assembly102 is provided below, particularly with reference to FIGS. 5-10 .Distal tip assembly 104 includes a tip 122, which is preferably slottedfor the reasons described herein, a tip connector 124, and a support armsleeve 126. A flushing tap 118 and a flushing tap lead 120 can beconnected to an introducer 116. Introducer 116 is preferably a tubularmember that is slidably located over outer delivery shaft 106.Introducer 116 may be formed of a variety of materials, for example,stainless steel or various polymer materials. A detailed description ofthe operation and structure of distal tip assembly 104 and introducer116 is provided below, particularly with reference to FIGS. 2-4 and 8-12. Catheter 100 is configured to be advanced along a guide wire (notshown). Preferably, the catheter is advanced over a 0.035 inch guidewire. However, the dimensions of the catheter components can be adjustedfor advancement over guide wires with larger or smaller diameters.

FIG. 2 illustrates catheter assembly 100 in an open configuration.Catheter assembly 100 reaches the open configuration when introducer 116is moved proximally along outer delivery shaft 106 to expose a valveretaining sleeve 204, a valve retaining sleeve connector 208, andsemi-sphere 202 of distal tip assembly 104. Valve retaining sleeveconnector 208 secures valve retaining sleeve 204 to the distal end ofthe outer delivery shaft 106. The outer delivery shaft 106 thereforeextends from the interior of handle assembly 102 to sleeve connector208. Slotted tip 122 and semi-sphere 202 are positioned on and connectedto the distal end of an intermediate delivery shaft 206. Intermediatedelivery shaft 206 extends from the interior of handle assembly 102 toslotted tip 122, to which the distal end of intermediate delivery shaft206 is attached. Intermediate delivery shaft 206 is encompassed by outerdelivery shaft 106 from the interior of handle assembly 102 until theouter delivery shaft 106 ends at sleeve connector 208. Semi-sphere 202is attached to the proximal end of slotted tip 122. In one embodiment,semi-sphere 202 can be attached directly to intermediate shaft 206.Intermediate shaft 206 is preferably a tubular member.

A guide wire shaft 504 (shown in FIG. 5 ) is encompassed withinintermediate shaft 206 and extends from the inside of handle assembly102 to the proximal end of slotted tip 122. Thus, in one embodiment ofthe present invention, at least three shafts extend from the mainhandle, and the shafts are nested along at least a part of theirlengths. Specifically, guide wire shaft 504 is encompassed by theintermediate delivery shaft 206 from a position inside of handleassembly 102 to the interior of slotted tip 122, which is preferablyhollow through at least a portion thereof. Intermediate delivery shaft206 is connected to, and ends, at the proximal end of slotted tip 122.In turn, intermediate delivery shaft 206 is encompassed by the outerdelivery shaft 106 from a position inside of handle assembly 102 to thevalve retaining sleeve connector 208. Outer delivery shaft 106 isconnected to, and ends, at the retaining sleeve connector 208.Intermediate shaft 206 and guide wire shaft 504 can be constructed ofvarious polymer materials, and may be braided structures using materialsdescribed above with reference to outer delivery shaft 106.

FIG. 3 is a depiction the distal tip assembly 104 and introducer 116 ofa catheter according to one embodiment of the present invention in aclosed configuration. Introducer 116, valve retaining sleeve 204,support arm sleeve 126, and tip connector 124 are rendered transparentin FIG. 3 in order to facilitate description of certain components. Tipconnector 124 is slidably positioned over the proximal end of slottedtip 122, as will be detailed below with reference to FIG. 4 . The distalend of intermediate delivery shaft 206 is connected to slotted tip 122.A simplified rendering of a prosthetic heart valve 304 is shown attachedto a valve retainer 302. Valve retainer 302 is also connected tointermediate delivery shaft 206. Valve retainer 302 serves to retainprosthetic valve 304 in place during delivery to the desired locationwithin a patient. Valve retainer 302 can be made from a polymer or metalmaterial suitable for exposure to a patient's circulatory system.Prosthetic valve 304 preferably has a frame that is formed from aself-expanding material, for example, Nitinol. This material allows thestructure to be contracted radially at a temperature different from thatof the body of the patient and to regain its original expanded shapewhen its temperature approaches or reaches that of the body of thepatient. The valve portion of prosthetic valve 304 can be made ofbiological tissue, such as bovine or porcine pericardium, or fromsynthetic materials. When in a closed configuration, at least a portionof prosthetic valve 304, and valve retainer 302, are encompassed byvalve retaining sleeve 204, and valve retaining sleeve 204 is in turnencompassed by introducer 116. In this configuration, the distal end ofintroducer 116 abuts the proximal end of support arm sleeve 126.

FIG. 4 illustrates the distal tip assembly 104 of a catheter inaccordance with one embodiment presented herein in a partially openconfiguration. As shown in FIG. 4 , tip connector 124 is affixed to theguide wire shaft 504 (not shown in FIG. 4 ) via a connecting fin 404.Connecting fin 404 is attached to the distal end of guide wire shaft504. An axial slot (not shown) in slotted tip 122 allows the connectingfin 404 to slide axially along slotted tip 122 when guide wire shaft 504is moved in a distal direction. As noted above, slotted tip 122 isaffixed to the distal end of intermediate delivery shaft 206. Theproximal end of intermediate delivery shaft 206 is preferably fixed in astationary position inside handle assembly 102. Thus, slotted tip 122and semi-sphere 202, which is preferably connected to slotted tip 122,are held in a fixed position by intermediate delivery shaft 206 whenguide wire shaft 504 is moved in an axial direction. In one embodiment,tip connector 124 is affixed to connecting fin 404 by over-molding thetip connector 124 around the connecting fin 404. It is understood thattip connector 124 can be affixed to fin 404 by any one of severalsuitable methods, such as a tongue and groove assembly, gluing, etc. Thedistal end of support arm sleeve 126 is connected to the proximal end oftip connector 124 so that the support arm sleeve 126 and tip connector124 move together. In the configuration shown in FIG. 4 , intermediatedelivery shaft 206 has been advanced distally while outer delivery shaft106 is retained in a fixed position.

FIG. 5 illustrates a delivery catheter handle assembly 102 in accordancewith one embodiment presented herein. Handle assembly 102 includes amain handle 108, a rotatable proximal control knob 110, and a rotatabledistal control knob 112. The handle sections of handle assembly 102 arepreferably connected using O-rings (not shown). As seen in FIG. 7 , knobpins 714 on the distal end of handle assembly 102 locate distal controlknob 112 on handle assembly 102. A circular channel (not shown) isformed on the interior surface of distal control knob 112, and thechannel receives knob pins 714, thereby preventing movement of distalcontrol knob 112 in an axial direction while permitting rotation ofdistal control knob 112 around the longitudinal axis of handle assembly102. Alternately, circular channels can be formed on handle assembly 102and control knobs 110 and 112 can include inwardly projecting tabs orinwardly projecting ridges configured to mate with the circular channelsto prevent axial movement of the knobs. Knob pins 716 located under theproximal end of proximal control knob 110 locate proximal control knob110 on handle assembly 102. A circular channel (not shown) is formed onthe interior surface of proximal control knob 110, and the channelreceives knob pins 716, thereby preventing movement of proximal controlknob 110 in an axial direction while permitting rotation of proximalcontrol knob 110 around the longitudinal axis of handle assembly 102. Itis understood that the handle sections can be connected using othermechanisms that would allow movement of the sections relative to eachother. Other structures can be used to secure control knobs 110 and 112to handle assembly 102 to prevent axial movement thereof. For example,circular ridges can be provided in handle assembly in place of pins 714and 716 in order to mate with the circular grooves formed on theinterior surfaces of knobs 110 and 112. A ratchet system can also beused to rotatably secure control knobs 110 and 112 to handle assembly102. Both proximal control knob 110 and distal control knob 112 arethreaded on their interior surfaces, as shown in further detail in FIG.6 . The configuration of the handle assembly 102 allows a user toprecisely control the movement of the guide wire shaft 504 and the outerdelivery shaft 106, and thereby manipulate the components of distal tipassembly 104. As shown in FIGS. 5-7 handle assembly 102 includes adistal guide wire shaft boss 616 configured to engage the inner threads602 of the distal control knob 112. Specifically, distal guide wireshaft boss 616 preferably has a tongue 617 that engages inner threads602 of distal control knob 112. Inner threads 602 are formed such that,as distal control knob 112 is rotated in a clockwise direction by auser, distal guide wire shaft boss 616 is forced in a distal direction,that is, towards the distal end of handle assembly 102. Distal guidewire shaft boss 616 is connected to proximal guide wire shaft boss 608by connecting bar 510. Proximal guide wire shaft boss 608 is connectedto guide wire shaft 504, Therefore, in operation, clockwise rotation ofdistal control knob 112 moves distal guide wire shaft boss 616 towardsthe distal end of handle assembly 102. Because distal guide wire shaftboss 616 is coupled to guide wire shaft 504 through connecting bar 510and proximal guide wire shaft boss 608, guide wire shaft 504 moves in adistal direction when distal guide wire shaft boss 616 moves in a distaldirection. Although a specific manner of connecting distal guide wireshaft boss 510 to guide wire shaft 504 is described above, it isunderstood that in other embodiments of the present invention, alternatemechanisms can be used to ensure that rotation of distal control knob112 results in axial movement of guide wire shaft 504.

Handle assembly 102 further includes an outer delivery shaft boss 612configured to engage the inner threads 604 of the proximal control knob110. Specifically, outer delivery shaft boss 612 preferably has a tongue618 that engages inner threads 604 of proximal control knob 110. Outerdelivery shaft boss 612 is connected to outer delivery shaft 106. Inoperation, counter-clockwise rotation of proximal control knob 110 movesouter delivery shaft boss 612 towards the proximal end of handleassembly 102. Because outer delivery shaft boss 612 is coupled to outerdelivery shaft 106, outer delivery shaft 106 moves in a proximaldirection when proximal control knob 110 moves in a proximal direction.Although a specific manner of connecting outer delivery shaft boss 612to outer delivery shaft 106 is described above, it is understood that inother embodiments of the present invention, alternate mechanisms can beused to ensure that rotation of outer delivery shaft boss 612 results inaxial movement of outer delivery shaft 106.

Handle assembly 102 also includes an intermediate delivery shaft 206.Intermediate delivery shaft 206 is fixedly secured to the inside of mainhandle 108, preferably by an O-ring. It is understood that intermediatedelivery shaft 206 can be secured to main handle 108 by other methods,for example, by welding, bolting, over-molding, etc. Guide wire shaft504 is encompassed by, but not affixed to, intermediate delivery shaft206 such that guide wire shaft 504 is axially movable with respect tointermediate delivery shaft 206. Intermediate delivery shaft 206 isencompassed by, but not affixed to, outer delivery shaft 106 such thatouter delivery shaft 106 is axially movable with respect to intermediatedelivery shaft 206. The entire catheter assembly 100 can be placed overa pre-positioned guide wire (not shown) by sliding guide wire shaft 504over the guide wire and out of guide wire port 512. Guide wire port 512can also be used as a supplemental flushing port. Handle assembly 102further includes a flushing channel 502 located within main handle 108.Flushing channel 502 is fluidly connected to the space between outerdelivery shaft 106 and intermediate delivery shaft 206 and the spacebetween intermediate delivery shaft 206 and guide wire shaft 504.Flushing channel 502 is fluidly connected to flushing port 114. In someembodiments, flushing channel 502 is fluidly connected to guide wireport 512 in addition to, or instead of, flushing port 114.

At the beginning of a procedure distal guide wire shaft boss 616 ispositioned towards the distal end of handle assembly 102, near distalcontrol knob pins 714, and outer delivery shaft boss 612 is positionedtowards the proximal end of its movement area, near proximal controlknob pins 716. When bosses 616 and 612 are in these initial positions,distal tip assembly 104 is generally in the configuration shown in FIG.3 , although distal tip assembly 104 could be previously advanced out ofintroducer 116. When in a closed configuration, heart valve 304 andvalve retainer 302 are encompassed by valve retaining sleeve 204, andvalve retaining sleeve 204 is in turn encompassed by introducer 116. Inthis configuration, the distal end of introducer 116 abuts the proximalend of support arm sleeve 126. Upon introduction into a body channel,distal tip assembly 104 is moved forward while introducer 116 is held ata fixed position, preferably at the apex of the heart after aminithoracotomy procedure, and distal tip assembly 104 is advanced untilprosthetic valve 304 reaches a desired implant location, preferably thenative valve annulus.

FIG. 8-10 illustrate distal tip assembly 104 in three stages ofdelivery. In FIG. 8 , distal tip assembly has been advanced within thebody such that prosthetic valve 304 is positioned and orientedapproximately in the native valve location. Distal tip assembly 104 isshown in FIG. 8 in a position that is reached after distal control knob112 of handle assembly 102 has been rotated in a clockwise direction bya user in order to partially advance distal guide wire shaft boss 616,and thereby guide wire shaft 504, towards the distal end of handleassembly 102. At the stage of delivery shown in FIG. 8 , distal guidewire shaft boss 616, and thereby guide wire shaft 504, have not reachedtheir maximum distal position. Advancing guide wire shaft 504 in adistal direction causes connecting fin 404, tip connector 124, andsupport arm sleeve 126 to advance in a distal direction over slotted tip122, and away from valve retaining sleeve 204, which remains in itsoriginal position because proximal control knob 110 has remained in itsoriginal position. Slotted tip 122 is also held stationary duringmovement of tip connector 124 and support arm sleeve 126 because it isconnected to intermediate delivery shaft 206, which is anchored inhandle assembly 102. As shown in FIG. 8 , valve prosthesis arms 802 arepartially exposed, but the support arm sleeve 126 is covering the distalend of arms 802.

To achieve the configuration of distal tip assembly 104 shown in FIG. 9, distal control knob 112 of handle assembly 102 is further rotated in aclockwise direction in order to advance distal guide wire shaft boss616, and thereby guide wire shaft 504, to their maximum distal location,that is, the location closest to distal control knob pins 714. Thisdistal movement of distal guide wire shaft boss 616 advances connectingfin 404, tip connector 124, and support arm sleeve 126 further distally,fully releasing valve prosthesis arms 802 from support arm sleeve 126.The proximal portion of valve 304, as well as valve retainer 302,remains encompassed by valve retaining sleeve 204. As a further resultof advancing support arm sleeve 126 to its furthest distal location,semi-sphere 202 protrudes from the proximal end of support arm sleeve126.

The clockwise and counterclockwise rotations of distal control knob 112and proximal control knob 110 described above are merely exemplary. Inembodiments of the present invention, the rotation of control knobs 110and 112 can be reversed, and control knobs 110 and 112 can be rotated inthe same direction. Inner threads 602 and 604 can be adjustedaccordingly to ensure that guide wire shaft 504 and outer delivery shaft106 move in the desired axial direction based on the rotationaldirection of control knobs 110 and 112.

To achieve the configuration of distal tip assembly 104 shown in FIG. 10, proximal control knob 110 of handle assembly 102 is rotated in acounterclockwise direction in order to move outer delivery shaft boss612 in a proximal direction, thereby withdrawing outer delivery shaft106, valve retaining sleeve 204, and valve retaining sleeve connector208 in a proximal direction. As noted above, valve retainer 302 is fixedto intermediate delivery shaft 206, and therefore does not experienceaxial movement when outer delivery shaft 106 or guide wire shaft 504 aremanipulated. In this configuration, valve 304 is fully released from theinside of valve retaining sleeve 204. The distal end of valve retainingsleeve 204 partially covers valve retainer 302. Once released from valveretaining sleeve 204, self-expanding prosthetic valve 304 expands to itsopen position in the native annulus.

After valve prosthesis 304 has been delivered to the native annulus,distal tip assembly 104 is prepared for removal from the body. As shownin FIG. 11 , distal tip assembly 104 is withdrawn through the expandedvalve prosthesis 304. Semi-sphere 202 provides a smooth, non-snagging,surface to aid in withdrawing support arm sleeve through the expandedvalve 304 without damaging the valve. Semi-sphere 202 also preventsinjuries to body channels as the distal tip assembly 104 is withdrawnfrom the body. Other structures can be used in place of semi-sphere inembodiments of the present invention. For example, semi-sphere 202 canbe replaced with a gently sloping cone or a semi-ellipsoid shape inorder to prevent support arm sleeve and other components from snaggingon prosthetic valve 304 as the catheter is removed from a patient'sbody. Semi-sphere 202 can be made from any semi-rigid polymer, metal, orother material suitable for exposure to a patient's circulatory system.

FIG. 12 illustrates the distal tip assembly 104 and introducer 116 shownin FIG. 3 in a second stage of withdrawal. In this stage, distal tipassembly 104 has been withdrawn to the apex of the heart. Semi-sphere202, valve retainer 302, valve retaining sleeve 204, and valve retainingsleeve connector 208 are encompassed by introducer 116. The distal endof introducer 116 mates with semi-sphere 202 and abuts the proximal endof support arm sleeve 126. Introducer 116 and distal tip assembly 104are then removed from the body.

A method of implanting a heart valve via a transapical approach using acatheter according to one embodiment of the present invention will bedescribed with reference to FIG. 13 . First, in step 1301, a patient'schest and heart apex are prepped for an implantation procedure,preferably by minithoracotomy or a similar procedure. Variouspreparation procedures that provide access to the heart can also be usedin embodiments of the present invention. For example, hemistemotomy orsternotomy can be used to gain access to the heart, although theseprocedures are less desirable because they are more invasive thanminithoracotomy and can result in extended post-operative recoverytimes. In step 1302, the user de-airs the catheter assembly 100 andplaces the catheter assembly 100 over a guide wire and advances thedistal tip assembly 104 through the minithoracotomy and to the apex ofthe heart. Slotted tip 122 penetrates the apex of the heart to allowaccess to the interior of the heart. In step 1303, the user positionsintroducer 116 across the apex of the heart, and advances the distal tipassembly 104 distally while holding the introducer stationary. In step1304, distal tip assembly 104 is advanced until the prosthetic valve 304is correctly positioned and oriented in the native valvular annulus.

Steps 1305 through 1307 release the prosthetic valve 304 from the distaltip assembly 104. In step 1305, the user rotates distal control knob 602to move the support arm sleeve 126 distally to release the proximal endof valve prosthesis arms 802. Note that the distal portion of valveprosthesis arms 802 are still contained within support arm sleeve 126,which allows the user to retract the arms 802 if the prosthetic valve304 is not correctly positioned. If the user is satisfied thatprosthetic valve 304 is properly positioned and oriented, the userfurther rotates the distal control knob 602 (step 1306) to advancesupport arm sleeve 126 further distally. This fully releases the valveprosthesis arms 802 from support arm sleeve 126. Then, in step 1307, theuser retracts the valve retaining sleeve 204 by rotating the proximalcontrol knob 110, allowing the prosthetic valve 304 to fully expand inthe native annulus.

In steps 1308-1310, the distal tip assembly 104 and introducer 116 areremoved from the body. First, in step 1308, semi-sphere 202, support armsleeve 126, tip connector 124, and slotted tip 122 are pulled backthrough the valve 304. Semi-sphere 202 prevents the support arm sleeve126 from snagging on and damaging valve 304. In step 1309, distal tipassembly 104 is withdrawn into introducer 116, which encloses thedevice. The introducer 116 and distal tip assembly 104 are thenwithdrawn from the heart and from the body (step 1310). The body canthen be closed up in the conventional fashion (step 1311).

Although the method described with reference to FIG. 13 has beendescribed with reference to a transapical approach, components andmethods according to embodiments of the present invention can be used inconjunctions with catheters designed for alternate approaches. Forexample, distal tip assembly 104 and/or handle assembly 102, orcomponents thereof, can be used in catheters designed for delivery of aheart valve via a transfemoral approach.

FIG. 14 illustrates a delivery catheter handle assembly 1402 accordingto another embodiment of the present invention including a support armrelease button 1403, also referred to herein as a safety button, thatprovides for increased accuracy in positioning and deploying aprosthetic heart valve at a desired location in the body. Theconstruction and configuration of handle assembly 1402 is similar inmany respects to that of handle assembly 102, and similar components arereferred to herein using the same reference numbers used to describe thecomponents of handle assembly 102. Handle assembly 1402 includes a mainhandle 108, a proximal control knob 110, and a distal control knob 112.The handle sections of handle assembly 1402 are preferably connectedusing O-rings (not shown), but other connection mechanisms are possible.A guide wire port 512 and a flushing port 114 are also provided, asshown in FIG. 15 . Outer delivery shaft 106 extends from the distal tipof handle assembly 1402. Handle assembly 1402 further includes a supportarm release button 1403 positioned on the distal tip 1404 of handleassembly 1402.

FIG. 15 is a cross-sectional view of handle assembly 1402. Handleassembly 1402 includes a distal guide wire shaft boss 616 configured toengage the inner threads 602 of the distal control knob 112. Distalguide wire shaft boss 616 is slidably located in a channel 1504,allowing axial movement of the distal guide wire shaft boss 616. Distalguide wire shaft boss 616 preferably has a tongue 617 that engages innerthreads 602 of distal control knob 112. Inner threads 602 are formedsuch that, as distal control knob 112 is rotated in a clockwisedirection by a user, distal guide wire shaft boss 616 is forced in adistal direction within channel 1504, that is, towards the distal end ofhandle assembly 1402 and the distal end of channel 1504. Distal guidewire shaft boss 616 is connected to proximal guide wire shaft boss 608by connecting bar 510. Proximal guide wire shaft boss 608 is slidablylocated in a channel 1508, allowing axial movement of the proximal guidewire shaft boss 608. Proximal guide wire shaft boss 608 is connected toguide wire shaft 504. Therefore, in operation, clockwise rotation ofdistal control knob 112 moves distal guide wire shaft boss 616 towardsthe distal end of channel 1504. Because distal guide wire shaft boss 616is coupled to guide wire shaft 504 through connecting bar 510 andproximal guide wire shaft boss 608, guide wire shaft 504 moves in adistal direction when distal guide wire shaft boss 616 moves in a distaldirection. Although a specific manner of connecting distal guide wireshaft boss 616 to guide wire shaft 504 is described above, it isunderstood that in other embodiments of the present invention alternatemechanisms can be used to ensure that rotation of distal control knob112 results in axial movement of guide wire shaft 504.

Handle assembly 1402 further includes an outer delivery shaft boss 612configured to engage the inner threads 604 of the proximal control knob110. Outer delivery shaft boss 612 is slidably located in a channel 1506allowing axial movement of the outer delivery shaft boss 612.Specifically, outer delivery shaft boss 612 preferably has a tongue 618(shown in FIG. 16A) that engages inner threads 604 of proximal controlknob 110. Outer delivery shaft boss 612 is connected to outer deliveryshaft 106. In operation, counter-clockwise rotation of proximal controlknob 110 moves outer delivery shaft boss 612 towards the proximal end ofchannel 1506. Because outer delivery shaft boss 612 is coupled to outerdelivery shaft 106, outer delivery shaft 106 moves in a proximaldirection when proximal control knob 110 moves in a proximal direction.Although a specific manner of connecting outer delivery shaft boss 612to outer delivery shaft 106 is described above, it is understood that inother embodiments of the present invention, alternate mechanisms can beused to ensure that rotation of outer delivery shaft boss 612 results inaxial movement of outer delivery shaft 106.

Handle assembly 1402 also includes an intermediate delivery shaft 206.Intermediate delivery shaft 206 is fixedly secured to the inside of mainhandle 108, preferably by an O-ring. It is understood that intermediatedelivery shaft 206 can be secured to main handle 108 by other methods,for example, by welding, bolting, over-molding, etc. Guide wire shaft504 is encompassed by, but not affixed to, intermediate delivery shaft206 such that guide wire shaft 504 is axially movable with respect tointermediate delivery shaft 206. Intermediate delivery shaft 206 isencompassed by, but not affixed to, outer delivery shaft 106 such thatouter delivery shaft 106 is axially movable with respect to intermediatedelivery shaft 206. The entire catheter assembly 100 can be placed overa pre-positioned guide wire (not shown) by sliding guide wire shaft 504over the guide wire and sliding the guide wire out of guide wire port512. Guide wire port 512 can also be used as a supplemental flushingport. Handle assembly 1402 further includes a flushing channel 502located within main handle 108. Flushing channel 502 is fluidlyconnected to the space between outer delivery shaft 106 and intermediatedelivery shaft 206 and the space between intermediate delivery shaft 206and guide wire shaft 504. Flushing channel 502 is fluidly connected toflushing port 114. In some embodiments, flushing channel 502 is fluidlyconnected to guide wire port 512 in addition to, or instead of, flushingport 114.

Handle assembly 1402 further includes a support arm release button 1403located on a distal tip section 1404. Support arm release button 1403 islocated in a radial channel 1510, allowing radial movement thereof.Preferably, support arm release button 1403 is spring loaded and ispre-biased in the upward position shown in FIG. 15 . A locking pin 1502is coupled, or formed integrally with, distal guide wire shaft boss 616.As will be described in further detail with reference to FIG. 17B,support arm release button 1403 includes a channel 1509 configured toreceive the distal portion of locking pin 1502. As shown in FIG. 15 ,when button 1403 is in its upwardly pre-biased position, channel 1509 isnot aligned with the distal portion of locking pin 1502. Thus, distalguide wire shaft boss 616 and locking pin 1502 are prevented fromadvancing to their full distal position in channel 1504 because thedistal portion of locking pin 1502 is blocked from advancing fully bythe bottom portion of button 1403, as shown in FIG. 17B. When downwardpressure is applied to button 1403, the button 1403 and channel 1509 areforced downward within channel 1510. When the button 1403 is fullydepressed, channel 1509 is generally aligned with the locking pin 1502.The distal tip of locking pin 1502 can then pass into channel 1509,allowing the distal guide wire shaft boss 616 to be advanced fullydistally in channel 1504. Some benefits of such a configuration aredetailed with respect to FIGS. 17 and 18 .

The size and shape of the support arm release button shown in FIG. 15 ismerely exemplary. It is understood that many button sizes and shapes canbe used. Button 1403 can be pre-biased in the upward configuration usinga variety of mechanisms other than spring loading. For example, button1403 can be provided with a tongue, which can be spring loaded, andhandle assembly 1402 can be provided with grooves to receive the tonguecorresponding to an upward position and a downward position of thebutton. After use, the button can be reset by a user to its upwardposition. In addition, other mechanisms can be used to place a channelin alignment with locking pin 1502. For example, a sliding tab having anangled bottom surface can be used in place of button 1403. Depending onthe orientation of the angled bottom surface, advancing the tabdistally, proximally, or left or right on the handle can force aspring-loaded button underneath the sliding tab downward in order toalign a channel in the button with the locking pin 1502. Alternately, alever having a channel therein can be used in place of button 1403. Inan initial position, the level can be positioned such that the channelis not aligned with locking pin 1502. By forcing the lever to either theright or left, depending on the location of the channel on the leverbody, the channel can be aligned with the locking pin 1502.

FIG. 16A illustrates the interior of handle assembly 1402 at a firstdelivery stage. FIG. 16B illustrates the configuration of distal tipassembly 104 corresponding to the handle configuration shown in FIG.16A. Distal tip assembly 104 has been described in detail above withreference to FIGS. 4 and 8-12 . At the beginning of a procedure, distalguide wire shaft boss 616 is positioned towards the proximal end ofchannel 1504, and outer delivery shaft boss 612 is positioned towardsthe distal end of channel 1506. When bosses 616 and 612 are in thesepositions, distal tip assembly 104 is generally in the configurationshown in FIG. 16B. When in a closed configuration, heart valve 304 (notshown in FIG. 16B) and valve retainer 302 are encompassed by valveretaining sleeve 204. Distal tip assembly 104 is moved forward whileintroducer 116 is held at a fixed position, preferably at the apex ofthe heart after a minithoracotomy procedure, and distal tip assembly 104is advanced until prosthetic valve 304 reaches a desired implantlocation, preferably the native valve annulus.

After the distal tip assembly has reached the desired implant locationarea, a user rotates distal control knob 112 in a clockwise direction inorder to partially advance distal guide wire shaft boss 616, and therebyguide wire shaft 504, towards the distal end of channel 1504. Thisconfiguration is shown in FIGS. 17A and 17B. Because support arm releasebutton 1403 is still in the pre-biased upward position, the distal guidewire shaft boss 616 cannot move past the point at which locking pin 1502abuts the button 1403, as shown in more detail in FIG. 17B. Thus, distalguide wire shaft boss 616, and thereby guide wire shaft 504, have notreached their maximum distal position. Advancing guide wire shaft 504distally to this point causes connecting fin 404, tip connector 124, andsupport arm sleeve 126 to advance in a distal direction over slotted tip122, and away from valve retaining sleeve 204, which remains in itsoriginal position because proximal control knob 110 has remained in itsoriginal position. Slotted tip 122 is also held stationary duringmovement of tip connector 124 and support arm sleeve 126 because it isconnected to intermediate delivery shaft 206, which is anchored inhandle assembly 1402. As shown in FIG. 17C, valve arms 802 are partiallyexposed, but the support arm sleeve 126 is covering the distal end ofarms 802. Thus, the inclusion of support arm release button 1403 andlocking pin 1502 decreases the incidence of operator error because auser can precisely advance the support arm sleeve 126 to the positionwhere the valve arms 802 are partially, but not completely, removed fromsupport arm sleeve 126. Specifically, when distal guide wire shaft boss616 has been advanced to the point where locking pin 1502 is abuttingbutton 1403, further rotation of distal control lamb 112 in a clockwisedirection is prevented.

To achieve the configuration of distal tip assembly 104 shown in FIG.18B, button 1403 is moved to its downward position in order to alignchannel 1509 with the distal end of locking pin 1502. Distal controlknob 112 is then further rotated in a clockwise direction in order toadvance the distal end of locking pin 1502 into channel 1509. Rotationcontinues until distal guide wire shaft boss 616 reaches the distal endof channel 1504, as shown in FIG. 18A. When this position is reached,further rotation of distal control knob 112 is prevented. This distalmovement of distal guide wire shaft boss 616, and thereby guide wireshaft 504, advances connecting fin 404, tip connector 124, and supportarm sleeve 126 further distally, fully releasing valve prosthesis arms802 from support arm sleeve 126. The proximal portion of valve 304, aswell as valve retainer 302, remains encompassed by valve retainingsleeve 204. As a further result of advancing support arm sleeve 126 toits furthest distal location, semi-sphere 202 protrudes from theproximal end of support arm sleeve 126.

As with handle assembly 102, the clockwise and counterclockwiserotations of distal control knob 112 and proximal control knob 110 onhandle assembly 1402 are merely exemplary. In embodiments of the presentinvention, the rotation of control knobs 110 and 112 can be reversed,and control knobs 110 and 112 can be rotated in the same direction.Inner threads 602 and 604 can be adjusted accordingly to ensure thatguide wire shaft 504 and outer delivery shaft 106 move in the desiredaxial directions based on the rotational direction of control knobs 110and 112.

To achieve the configuration of distal tip assembly 104 shown in FIG.19B, proximal control knob 110 of handle assembly 1402 is rotated in acounterclockwise direction in order to move outer delivery shaft boss612 in a proximal direction, thereby withdrawing outer delivery shaft106, valve retaining sleeve 204, and valve retaining sleeve connector208 in a proximal direction. Valve retainer 302 is fixed to intermediatedelivery shaft 206, and therefore does not experience axial movementwhen outer delivery shaft 106 or guide wire shaft 504 are manipulated.In this configuration, valve 304 is fully released from the inside ofvalve retaining sleeve 204. The distal end of valve retaining sleeve 204partially covers valve retainer 302. Once released from valve retainingsleeve 204, self-expanding prosthetic valve 304 expands to its openposition in the native annulus.

After valve prosthesis 304 has been delivered to the native annulus, thecatheter assembly is withdrawn from the body in the manner describedabove with reference to FIGS. 11 and 12 .

FIGS. 20-23 illustrate a catheter handle assembly 2002 according to oneembodiment of the present invention. Handle assembly 2002 is generallyconstructed and operated in the manner described above with reference tohandle assembly 1402 in FIGS. 14-19B. However, handle assembly 2002features an alternative embodiment of a support arm release button 2003according to another embodiment of the present invention. Support armrelease button 2003 is preferably spring loaded and biased in the upwardposition shown in FIG. 21 , but other attachment and operation methodscan be used, as described above with reference to handle assembly 1402.As shown in FIG. 21 support arm release button 2003 is formed with achannel 2102 therein. At the proximal end of channel 2102, a locking tab2002 is formed, which extends upward from the bottom surface of channel2102. A corresponding notch 2104 is formed in locking pin 1502, which isattached to distal guide wire shaft 616 as described above. As picturedin FIG. 21 , distal control knob 112 has been rotated in a clockwisedirection to move distal guide wire shaft boss 616 distally withinchannel 1504. The distal tip of locking pin 1502 abuts the bottomportion of button 2003, thereby preventing further rotation of distalcontrol knob 112 and signaling a user that the distal tip assembly 104has reached the position shown in FIG. 17C.

As shown in FIG. 22 , support arm release button 2003 is then pressedand thereby moved to its downward position, aligning channel 2102 withthe distal tip of locking pin 1502. The distal tip of locking pin 1502is then able to enter channel 2102, and distal control knob 112 can berotated to bring distal guide wire shaft boss 616 to its most distalposition in channel 1504, as shown in FIG. 23 . At this point, distaltip assembly 104 of the catheter is in the position shown in FIG. 18B.When guide wire shaft boss 616 is in its most distal position, lockingtab 2106 is aligned with notch 2104 in locking pin 1502. Support armrelease button 2003 rises slightly due to its spring-loaded upward bias,thereby locking the locking pin 1502 in position because tab 2106 ismated with notch 2106. This locking action prevents unintentionalrotation of distal control knob 112 during an implantation procedure,thereby ensuring that support arm sleeve 126 remains in its most distalorientation, shown in FIG. 18B, as the remainder of the procedure isperformed.

Handle assemblies 1402 and 2002 can be substituted for handle assembly102 in catheter 100. Heart valves can be implanted in a patientutilizing handle assembly 1402 or handle assembly 2002 in conjunctionwith catheter 100 in generally the same manner as described withreference to FIG. 13 , with the following modifications to steps 1305and 1306. In step 1305, when using handle assembly 1402 or 2002, theuser rotates distal control knob 612 to move the support arm sleeve 126distally to release the proximal end of valve prosthesis arms 802 untilthe distal end of locking pin 1502 abuts the support arm release button1403 or 2003. The distal portion of valve prosthesis arms 802 are stillcontained within support arm sleeve 126 at this point, which allows theuser to reposition the prosthetic valve 304 if the valve arms 802 arenot correctly positioned. If the user is satisfied that prosthetic valve304 is properly positioned and oriented, the user applies downwardpressure to support arm release button 1403 or 2003 in order to alignchannel 1509 or 2102 with the distal end of locking pin 1502, andfurther rotates the distal control knob 612 to advance support armsleeve 126 to its maximum distal position relative to slotted tip 122(step 1306). With respect to handle assembly 2002, this action locks thedistal control knob 112, preventing further rotation thereof in anydirection. This fully releases the valve prosthesis arms 802 fromsupport arm sleeve 126. Operation of proximal control knob 110 andwithdrawal of the catheter assembly from the body can then proceed asdetailed in steps 1307-1311.

The foregoing description of the invention has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed.Other modifications and variations may be possible in light of the aboveteachings. The embodiments and examples were chosen and described inorder to best explain the principles of the invention and its practicalapplication and to thereby enable others skilled in the art to bestutilize the invention in various embodiments and various modificationsas are suited to the particular use contemplated. It is intended thatthe appended claims be construed to include other alternativeembodiments of the invention.

EXAMPLES

The following paragraphs serve as examples of the above-describedembodiments.

Example 1

One embodiment provides a catheter for delivering an expandableprosthesis, the catheter having a proximal end and a distal end. Thecatheter includes a handle assembly on the proximal end of the catheter.The handle assembly includes a rotatable distal control knob and arotatable proximal control knob. A distal tip assembly including a firstsleeve and a second sleeve is provided on the distal end of thecatheter. The catheter has a first elongate member extending from thehandle assembly. The first elongate member has a proximal end and adistal end and the first sleeve is connected to the distal end of thefirst elongate member. The catheter also has a second elongate memberextending from the handle assembly. The second elongate member has aproximal end and a distal end and the second sleeve is connected to thedistal end of the second elongate member. A safety button is provided onthe handle assembly. The rotatable distal control knob is movablyconnected to the first elongate member, and the catheter is configuredsuch that rotation of the rotatable distal control knob advances thefirst sleeve in a distal direction. The safety button is configured tolock the rotatable distal control knob in place after the first sleevehas been advanced. The rotatable proximal control knob is moveablyconnected to the second elongate member, and the catheter is configuredsuch that rotation of the rotatable proximal control knob moves thesecond sleeve in a proximal direction.

Example 2

Another embodiment provides a handle assembly for a delivery catheterhaving a distal end and a proximal end. The handle assembly includes afirst hollow elongate member partially housed within the handleassembly, and a second hollow elongate member partially housed withinthe handle assembly. The second hollow elongate member is encompassedalong at least a portion of its length by the first hollow elongatemember, and the first and second hollow elongate members are axiallymovable with respect to one another. The handle assembly furtherincludes a first rotatable control knob movably connected to the firsthollow elongate member. The handle assembly is configured such thatrotation of the first rotatable control knob moves the first hollowelongate member in an axial direction. A second rotatable control knobis also provides, and is movably connected to the second hollow elongatemember. The handle assembly is configured such that rotation of therotatable proximal control knob moves the second hollow elongate memberin an axial direction. A safety button is included with the handleassembly for locking the second rotatable control knob in a desiredposition.

Example 3

Another embodiment provides a handle assembly for a delivery catheterhaving a distal end and a proximal end. The handle assembly includes amain handle having a distal end and a proximal end. A rotatable distalcontrol knob is rotatably connected to the main handle at the distal endof the main handle. The distal control knob includes threads formed onthe interior surface thereof. A rotatable proximal control knob isrotatably connected to the main handle proximal to the distal controlknob. The proximal control knob includes threads formed on the interiorsurface thereof. A first elongate member extends from the handleassembly. The first elongate member has a proximal end and a distal end.A second elongate member extends from the handle assembly. The secondelongate member has a proximal end and a distal end. A first boss havinga tongue for engaging the distal control knob threads is included in thehandle assembly. A second boss is also included. The second boss isconnected to the first boss and the first elongate member such thataxial movement of the first boss results in corresponding axial movementof the second boss. A locking rod is attached to the first boss. Asafety button is positioned on the main handle distal of the distalcontrol knob. The safety button has a channel therein configured toreceive a portion of the locking rod. A third boss is included. Thethird boss has a tongue for engaging the proximal control knob threads.The third boss is connected to the second elongate member.

What is claimed is:
 1. A prosthetic valve delivery device comprising: ahandle assembly including a handle, a first control member, a lockingpin coupled to the first control member, and a safety component, thesafety component being configured to be movable relative to the lockingpin between an initial position and a secondary position, wherein thesafety component is coupled to the handle in the initial position and iscoupled to the handle in the secondary position; a distal tip assemblyincluding a first sleeve; and a first elongate member extending from thehandle assembly, the first elongate member having a proximal end and adistal end and the first sleeve being connected to the distal end of thefirst elongate member, wherein the first control member is connected tothe proximal end of the first elongate member, and wherein manipulationof the first control member concurrently moves the first sleeve and thelocking pin in an axial direction, and wherein the locking pin isconfigured to be moveable via manipulation of the first control memberfrom a first position in which the locking pin does not engage thesafety component to a second position in which the locking pin engagesthe safety component and thereby locks the first sleeve in place.
 2. Thedevice of claim 1, wherein the safety component includes a recess formedtherein, and wherein the safety component is configured to be moveablefrom the initial position in which the recess of the safety component isnot aligned with the locking pin and the locking pin is blocked frombeing advanced into the recess of the safety component to the secondaryposition in which the recess of the safety component is aligned with thelocking pin and the locking pin is not blocked from being advanced intothe recess of the safety component.
 3. The device of claim 2, whereinthe safety component is biased in the first initial position.
 4. Thedevice of claim 2, wherein the safety component is movable in a radialdirection.
 5. The device of claim 4, wherein the safety componentcomprises a safety button.
 6. The device of claim 2, wherein the safetycomponent is movable in a distal or proximal direction.
 7. The device ofclaim 2, wherein the safety component is movable in a lateral direction.8. The device of claim 1, further comprising a second elongate member,wherein each of the first elongate member and second elongate member arehollow, and wherein the first elongate member is encompassed along atleast a portion of its length by the second elongate member, and whereinthe first elongate member and the second elongate member are axiallymovable with respect to one another.
 9. The device of claim 1, whereinthe first control member comprises a rotatable control knob.
 10. Thedevice of claim 9, wherein the rotatable control knob is rotatablearound a longitudinal axis of the handle assembly.
 11. The device ofclaim 1, wherein manipulation of the first control member moves thefirst sleeve to at least partially release a prosthetic valve at leastpartially contained within the first sleeve.
 12. The device of claim 1,wherein the locking pin is configured to prevent manipulation of thefirst control member when the locking pin is in the second position. 13.The device of claim 1, wherein the locking pin is disposed within achannel in an interior of the handle assembly.
 14. The device of claim1, wherein the device is configured for transapical delivery of aprosthetic heart valve.
 15. The device of claim 1, wherein the device isconfigured for transfemoral delivery of a prosthetic heart valve.
 16. Aprosthetic valve delivery device comprising: a handle assembly includinga handle, a first control member, a locking pin coupled to the firstcontrol member, and a safety component, the safety component beingconfigured to be movable relative to the locking pin between an initialposition and a secondary position, wherein the safety component iscoupled to the handle in the initial position and is coupled to thehandle in the secondary position; a distal tip assembly including afirst sleeve; and a first elongate member extending from the handleassembly, the first elongate member having a proximal end and a distalend and the first sleeve being connected to the distal end of the firstelongate member, wherein the first control member is connected to theproximal end of the first elongate member, and wherein manipulation ofthe first control member concurrently moves the first sleeve and thelocking pin in an axial direction, and wherein the locking pin isconfigured to be moveable via manipulation of the first control memberfrom a first position in which the locking pin does not engage thesafety component to a second position in which the locking pin engagesthe safety component, the locking pin being configured to preventmanipulation of the first control member when in the second position.17. The device of claim 16, wherein the safety component includes arecess formed therein, and wherein the safety component is configured tobe moveable from the initial position in which the recess of the safetycomponent is not aligned with the locking pin and the locking pin isblocked from being advanced into the recess of the safety component tothe secondary position in which the recess of the safety component isaligned with the locking pin and the locking pin is not blocked frombeing advanced into the recess of the safety component.
 18. The deviceof claim 17, wherein the safety component is movable in a radialdirection and is biased in the initial position.
 19. The device of claim16, wherein manipulation of the first control member moves the firstsleeve to at least partially release a prosthetic valve at leastpartially contained within the first sleeve.
 20. The device of claim 16,wherein the locking pin is disposed within a channel in an interior ofthe handle assembly.